News - Drug Law Journal

Jury Finds That Pharmacy Chains Played Substantial Role in Opioid Epidemic

Posted on November 29, 2021November 29, 2021

Last week, a federal jury in Cleveland found that three large pharmacy chains — CVS Health, Walmart, and Walgreens — played a substantial role in the opioid epidemic in two Ohio counties, Lake and Trumbull. This ruling marks the first time in the decades-long crisis that the retail section of the drug industry has been held responsible.

Pharmacy Chains Found Guilty in Recent Trial

Lawyers for the plaintiffs argued that the pharmacy chains had repeatedly ignored numerous red flags about questionable opioid orders, both at the counters where patients picked up their prescriptions and at corporate headquarters. Following hearings to be held this spring, the trial judge will decide how much each company must pay.

“It’s the first opioid trial against these major households names,” explained Adam Zimmerman, a mass litigation professor at Loyola Law School in Los Angeles. “They have been the least willing group of defendants to settle, so this verdict is at least a small sign to them that these cases won’t necessarily play out well in front of judges.” He believes some pharmacy defendants may choose to settle instead of going to trial.

Prior to this ruling, the public nuisance argument was rejected twice in cases against opioid manufacturers, in both California and Oklahoma. The judges ruled that, based on each state’s public nuisance laws, the companies were too far removed from the overdoses and deaths to be declared at fault.

Still, plaintiffs in thousands of lawsuits across the nation found the verdict to be encouraging. They are all relying on the same trial strategy: that pharmacies contributed to the “public nuisance” in the opioid crisis.

What’s Next for Opioid Epidemic Lawsuits

Zimmerman noted the opioid lawsuits still have a long way to go. “It’s more like there are many different ballgames going on at once, each with slightly different rules, and we’re in the early innings of almost all of them,” he said. Plus, because each state has slightly different public nuisance laws, the recent outcome may have little bearing on upcoming cases.

The first opioid case was filed in 2014. Despite thousands of ongoing trials, the urgency of getting help to deeply-impacted communities has not slowed. In fact, new data released earlier this month shows that deaths from opioids reached record levels during the pandemic, driven by illegal drugs like heroin and street fentanyl.

For more information about the opioid epidemic and lawsuits, contact us today.

Additional Reading:

Johnson & Johnson Agrees to $297M Opioid Deal with Texas, National Deal Faces Holdouts

Pharmacies Face First Trial for Role in Opioid Crisis

Tentative Opioid Settlement For $26 Billion Focuses on Treatment, Prevention, and Education

Court Upholds $86M Reward to California Couple in Roundup Case

Posted on November 22, 2021November 22, 2021

Monsanto Co. challenged a reward of $86.2 million in damages to a couple who developed cancer after three decades of using Roundup weed killer. Last week, California’s highest court rejected this objection. It upheld the original ruling of the Roundup case in favor of Alva and Alberta Pilliod.

Responses to Recent Roundup Case Ruling

In August, the First District Court of Appeal in San Francisco declared in a 2-1 ruling that Monsanto was to blame for knowingly marketing and selling a product with a potentially dangerous active ingredient.

Parent company Bayer disagreed with this decision. In a statement, the company said, “We continue to stand strongly behind the safety of Roundup, a position supported by assessments of expert regulators worldwide as well as the overwhelming weight of four decades of extensive science.”

Brent Wisner, a lawyer for the plaintiffs, shared with the San Francisco Chronicle that the ruling “was based on solid science and unanimous law.” He encouraged the company to stop with its “frivolous appeals.”

The Future of Roundup Settlements

Over the summer, Bayer revealed that it would stop selling the current version of Roundup for home and garden use in U.S. stores in 2023. The company plans to replace the main ingredient, glyphosate, with a new ingredient. This ingredient change is still subject to federal and state approval. They will continue to sell Roundup with glyphosate for farm use.

Thus far, Bayer has agreed to pay $10 billion to settle thousands of lawsuits at both the state and federal level. They have also tried to resolve future lawsuits with a settlement of up to $2 billion. So far, these efforts have been unsuccessful.

For more information about the lawsuits related to Roundup, contact us today.

Additional Reading:

Bayer Roundup Trial Goes Virtual Due to COVID-19 Concerns

Bayer Loses Third Consecutive Appeal of Roundup Cancer Verdict

Jury Awards Record $13 Million in 3M Bellwether Trial

Posted on November 18, 2021November 18, 2021

Earlier this week, in Tallahassee, Florida, a federal court jury awarded $13 million to Guillermo Camarillorazo in the latest 3M bellwether trial.

Largest Single Plaintiff Award in 3M Bellwether Trial

Camarillorazo is a U.S. Army sergeant who claimed to suffer hearing damage as a result 3M’s military-issue earplugs. The verdict, under the jurisdiction of Northern District of Florida Chief Judge Mark Walker, included about $800,000 in compensatory damages and $12.25 million in punitive damages. This bellwether trial is the seventh one in a large multi-district litigation (MDL) concerning the Combat Arms Earplugs version 2 (CAEv2). It was the largest award yet for a single plaintiff.

This decision closely followed a verdict in favor of 3M. On Friday, November 12, a Pensacola jury, presided over by Northern District of Alabama Judge Liles Burke, rejected similar claims by Army veteran Joseph Palanki. In total, plaintiffs have won four trials, and 3M, three.

Regarding Monday’s loss, 3M said it was “disappointing” and plans to appeal. Conversely, the company believes that Friday’s verdict was an “important demonstration that jurors agree 3M’s CAEv2 product was safe and effective to use.”

Plaintiff lawyers believe that Camarillorazo “successful held 3M accountable for putting profits over the safety of those who served our nation.” In a separate statement, they shared their “deep respect and admiration” for Palanki and noted their confidence towards future trials.

Were You Issued 3M Combat Arms Earplugs and Now Suffer Tinnitus and/or Hearing Loss?

What’s Next for 3M MDL

3M is facing more than 270,000 claims over the earplugs, which the U.S. military used between 2003 and 2015. The plaintiffs argue that they suffered hearing loss and damage, including tinnitus (a persistent ringing in the ears), because the earplugs were defective. 3M denies the claims.

Most of the cases are consolidated in the MDL before U.S. District Judge M. Casey Rodgers in the Northern District of Florida. In the first five 3M bellwether trials, juries awarded a total of over $15 million to five plaintiffs. Nine more bellwether trials are scheduled between now and the end of May 2022.

For more information about the 3M bellwether trails and most recent settlement, contact us today.

Additional Reading:

Fifth Bellwether Trial for 3M Combat Earplugs Results in Defense Verdict

Florida Jury Awards $8.2 Million Against 3M Over Defective Combat Earplugs

3M Earplug Cases Sped Up Due to Backlog

Jury Verdict for Plaintiffs in Latest 3M Earplug Lawsuit

Opioid Manufacturers Win Major Victory in California

Posted on November 15, 2021November 15, 2021

Earlier this month, a California judge rejected an argument being used in thousands of cases against the pharmaceutical industry for its role in the opioid epidemic. The abuse of these drugs has led to the deaths of over 500,000 people in the United States since the 1990s. Unfortunately, the crisis has worsened during the COVID-19 pandemic. This decision marks the first major legal victory for four opioid manufacturers, which include Johnson & Johnson, Teva, Allergan, and Endo Pharmaceuticals.

Major Victory for Opioid Manufacturers

Filed in 2014, this case was brought by the counties of Santa Clara, Los Angeles, and Orange as well as the city of Oakland. It was one of the first proceedings to demand that drug manufacturers be held accountable for the epidemic. Specifically, the trial focused on whether the companies were responsible for creating “a public nuisance.” This reasoning has been argued by local California governments as well as many individual plaintiffs pursuing cases across the country.

Judge Peter Wilson represented the Orange County State Superior Court and presided over the four-month bench trial. “There is simply no evidence to show that the rise in prescriptions was not the result of the medically provision of pain medications to patients in need,” he wrote of his decision.

Specifically, Judge Wilson declared that, if the companies did engage in misleading marketing, “any adverse downstream consequences flowing from medically appropriate prescriptions cannot constitute an actionable public nuisance.” In other words, it would be impossible to determine the increase in legitimate prescriptions versus those that were ill-acquired. Even so, he acknowledged the seriousness of the opioid epidemic.

Future Implications of the Ruling

The ruling confirmed what legal experts have claimed since the beginning of litigation: that assigning responsibility of the epidemic will be difficult due to the many hands involved in the prescription process. The opioids pass from the manufacturers, distributors, doctors, and pharmacies before ever reaching a patient. Plus, the drugs are federally-approved for pain management, making it challenging to determine where the patient need ends and the misuse begins.

This major victory for manufacturers may or may not impact other trials, as so few cases have been decided thus far. Still, there are reasonable implications of the decision. “It’s the first defense win, so it suggests that maybe, as these cases are litigated instead of being settled, there are opportunities for defendants to score victories,” explained Adam Zimmerman, a professor at Loyola Law School in Los Angeles.

For more information about the opioid epidemic and lawsuits, contact us today.

Additional Reading:

Johnson & Johnson Agrees to $297M Opioid Deal with Texas, National Deal Faces Holdouts

Pharmacies Face First Trial for Role in Opioid Crisis

Tentative Opioid Settlement For $26 Billion Focuses on Treatment, Prevention, and Education

FDA Announces Expanded Recall of All 0.5mg and 1mg Chantix Pills

Posted on November 11, 2021November 11, 2021

The U.S. Food and Drug Administration (FDA) recently announced an expanded recall of Chantix (varenicline) to include all lots of 0.5mg and 1mg tablets. Pfizer is pulling the smoking cessation drug because of concerning levels of N-nitroso-varenicline, which may be associated with an increased risk of cancer in humans.

Timeline of Expanded Recall for Chantix

On July 2, 2021, the FDA first notified patients and providers about the recall of nine lots of Chantix. At this point, Pfizer recalled a limited number of products due to the presence of the nitrosamine.

Nitrosamines are commonly found in water and foods, meaning that everyone is exposed to them in some way. However, the risk of cancer may increase if people are exposed at high levels over a long period of time. Still, the FDA noted that there was no immediate risk to patients taking the mediation. In fact, the benefits of quitting smoking outweighed the theoretical and potential risk of cancer.

Pfizer continued selling the believed-to-be safe lots of the smoking cessation drug. Then, on July 19, 2021, the company expanded the recall to 12 lots, based on the same concern as the initial recall.

Approximately a month later, on August 18, 2021, the manufacturers added four more lots to the list. Then, per the most recent update, Pfizer issued a statement about the final expanded recall, which is inclusive of all lots of of the 0.5mg and 1mg tablets. As they work to reduce or eliminate the impurity in future lots, the FDA said that it would not object to “certain manufacturers distributing varenicline tablets containing N-nitroso-varenicline above the acceptable limit intake of 37ng per day but below the interim acceptable intake limit of 185ng per day.”

Connection to Other Recent Recalls

Similarly, the FDA requested the removal of all Zantac from shelves in April 2020. There was concern that the heartburn drug contained unsafe levels of N-nitrosodimethylamine (NDMA), another impurity related to cancer. As a result, multiple lawsuits have been filed against the manufacturers.

Several other drugs, including high blood pressure medications like valsartan and losartan, have been impacted by nitrosamine impurities in recent years. This issue may be caused by changes in manufacturing as well as improved testing methods that allow the components to be identified at very low levels.

For more information about the halted distribution of Chantix, contact us today.

Additional Reading:

Pfizer Halts Sales of Chantix Due To Possible Carcinogen Contamination

Farmworker and Environmental Groups Sue EPA Over Approval of Paraquat

Posted on November 8, 2021November 8, 2021

In late September, farmworker and environmental groups sued the Environmental Protection Agency (EPA) over its summer re-approval of the weedkiller paraquat, which is primarily used for soybean, corn, and cotton crop fields. These groups argue that it puts farmworkers at an increased risk for developing Parkinson’s disease, a degenerative brain disease that leads to loss of muscle coordination.

Petition Against EPA’s Decision

The Farmworker Association of Florida (FWAF), along with other groups, petitioned the 9th U.S. Circuit Court of Appeals, asking them to review the EPA’s decision to approve continued use of the herbicide. They claim the weedkiller violates the Federal Insecticide, Fungicide, and Rodenticide Act.

When issuing its July approval, the agency revealed that there was insufficient evidence to link exposure to this herbicide and Parkinson’s disease. However, a growing number of liability lawsuits focus on the connection between paraquat and the degenerative disease. In June, the Judicial Panel on Multi District Litigation (MDL) consolidated the mass tort litigation against paraquat’s makers in the Southern District of Illinois. Because litigation is pending, EPA spokesperson Ken Labbe declined to comment.

Syngenta, one of the herbicide’s major sellers, markets the product as Gramoxone. Spokesperson Paul Minehart declined to comment on the new 9th Circuit case due to a “mandatory quiet period” ahead of its initial public offering on the Shanghai Stock Exchange. The company has previously agreed with the EPA and said there was “no credible evidence” to suggest paraquat usage leads to Parkinson’s.

Paraquat Usage Linked to “Unreasonable Risks”

The plaintiffs, however, said in a statement that some studies have found that paraquat can increase the risk of Parkinson’s. Jeannie Economos, a pesticide safety project coordinator with the FWAF, said that it is “unconscionable that the EPA so devalues the lives of farmworkers as to allow the continued us of this harmful toxic pesticide.” Earthjustice represents the plaintiffs, including FWAF and The Michael J. Fox Foundation for Parkinson’s Research.

The groups also criticized the agency for re-approving the substance despite determining that “exposure to paraquat can damage the respiratory system and eyes,” exposing farmworkers to “unreasonable risks.”

The EPA first registered paraquat in 1964. It must undergo a registration review every 15 years. The product has already been banned in many parts of the world, including by the European Union, China, and Brazil.

If you or a loved one is impacted by this litigation, please contact us today for a free case evaluation.

Fifth Bellwether Trial for 3M Combat Earplugs Results in Defense Verdict

Posted on November 4, 2021November 4, 2021

A jury recently declared a defense verdict in a lawsuit between 3M and a U.S. Army veteran who claimed she suffered hearing damage after using the company’s Combat Arms Earplugs version 2 (CAEv2). This trial was the fifth one chosen as a test case, or a bellwether, in a multi district litigation (MDL) over the defective earplugs.

Defense Verdict in Fifth Bellwether Trial for 3M

Michelle Blum alleged that she developed both hearing loss and tinnitus, a constant ringing in her ears, as a result of using the earplugs during her service in the U.S. Army Reserves, National Guard, and Army between 1989 and 2009. Her attorney are Bryan Aylstock of Aylstock Witkin Kreis & Overholtz, Shelley Hutson of Clark, Love & Hutson, and Chris Seeger of Seeger Weiss.

Her legal team is, of course, disappointed in the verdict. “We continue to believe that the evidence overwhelmingly demonstrates that 3M knew their CAEv2 earplugs were defective yet allowed our service members who relied on them for hearing protection to suffer from preventable hearing loss and tinnitus,” they said in a joint statement.

3M, however, believes that the results confirm their “confidence in [the] case and shows that plaintiffs face significant challenges — not just here but in all the trials in this litigation — as each case must be proven on its own facts.”

History of Allegations Against 3M’s Defective CAEv2

There are over 270,000 claims against the company due to their earplugs. CAEv2 were standard issue for much of the U.S. military between 2003 and 2015. Most of the lawsuits are consolidated before U.S. District Judge M. Casey Rodgers in the Northern District of Florida. It is the largest MDL in history.

Overall, plaintiffs have won in three of the five bellwether trials and been awarded about 15 million dollars to five individuals. Eleven trials are currently scheduled, with the first one beginning this week.

For more information about the 3M MDL and most recent settlement, contact us today.

Additional Reading:

Florida Jury Awards $8.2 Million Against 3M Over Defective Combat Earplugs

3M Earplug Cases Sped Up Due to Backlog

Jury Verdict for Plaintiffs in Latest 3M Earplug Lawsuit

Johnson & Johnson Agrees to $297M Opioid Deal with Texas, National Deal Faces Holdouts

Posted on November 1, 2021November 1, 2021

Johnson & Johnson (J&J) and the top three drug distributors previously agreed to a national opioid settlement for 26 billion dollars. However, because that deal is not yet finalized, the pharmacy company is moving forward with a separate deal in Texas.

New Settlement for Johnson & Johnson and Texas

For the new deal, which is consistent with the nationwide settlement, J&J will pay Texas 297 million dollars to put towards opioid claims from the state and its municipalities. The national deal, then, will no longer included this settlement amount. Additionally, J&J will no longer be a defendant in pending opioid litigation in the state, which includes two bellwether trials planned for early next year.

The pharmacy company clarified that the settlement with Texas is not an admission of guilt. They believe that their opioid marketing was “appropriate and responsible.”

National Opioid Deal

The national deal was created in July between J&J, drug distributors, states, and localities. Unfortunately, it is still seeking the needed support and not yet finalized. Eight states have yet to sign on, according to Reuters. In this settlement, J&J agreed to pay 5 billion dollars, while the distributors agreed to pay 21 billion dollars.

The Texas deal isn’t completed until 96 percent of the localities that filed lawsuits against J&J are signed on. This new settlement is an attempt by Texas to secure payout regardless of the outcome of the national deal.

J&J has also defended itself against talc litigation in past years. Recently, the pharmaceutical company said they would move its talc business to a new subsidiary and declare bankruptcy for the current business. They have set aside billions of dollars to deal with thousands of lawsuits that link their talc products to cancer. Plaintiffs are arguing against the bankruptcy approach.

For more information about the opioid crisis and settlement, contact us today.

Additional Reading:

Pharmacies Face First Trial for Role in Opioid Crisis

Tentative Opioid Settlement For $26 Billion Focuses on Treatment, Prevention, and Education

Johnson & Johnson Agrees to End Opioid Business With $230 Million Settlement

Opioids

Study Finds That E-Cigarettes Don’t Prevent Smoking Relapse

Posted on October 28, 2021October 28, 2021

According to the results of a new longitudinal study, using e-cigarettes and other tobacco products to prevent smoking relapse is not effective. Nearly 13,000 smokers in the United States participated in this research. It is the first study to report on whether cigarette smokers can switch to e-cigarettes and successfully quit using cigarettes.

Use of E-Cigarettes to Prevent Smoking Relapse

“Quitting is the most important thing a smoker can do to improve their health,” explained study author John Pierce. “But the evidence indicates that switching to e-cigarettes made it less likely, not more likely, to stay off of cigarettes.”

Specifically, the research found that 50 percent of former smokers who quit “cold turkey” were still non-smokers as of the second annual follow-up. Only 41.5 percent of former smokers who used an alternative form of tobacco in their quitting efforts found success. “Those who switched to e-cigarettes (or indeed another form of tobacco) were 8.5 percent more likely to relapse to cigarettes,” said Pierce, a professor of family medicine and public health at the UC San Diego Institute for Public Health.

The study did not consider the use of nicotine replacement therapy (NRT), which is specifically designed to help people stop smoking. Those therapies include patches, gum, and lozenges that contain limited amounts of nicotine.

Harmful History of Vaping

E-cigarettes are often used a nicotine alternative for smokers trying to quit. They work by using an often-flavored liquid called e-juice, which eventually vaporizes. Vaping eliminates the over 7,000 chemicals, including the toxic ones, that are found in a burning cigarette.

Vaping became popular for tobacco cessation after a study out of the United Kingdom found that e-cigarettes helped as many as 70,000 smokers in England quit smoking in 2017. However, their use is now controversial due to potential long-term health effects from chemicals in the vape juice or cartridge.

Additionally, multiple studies determined that teen vaping often leads to cigarette smoking. American youth also dealt with a serious outbreak of a vaping-related lung disease, now known as EVALI (e-cigarette or vaping use-associated lung injury), in 2019. According to the Centers for Disease Control and Prevention, as of February 2020, the illness had killed at least 68 people and sickened over 28,000 e-cigarette users.

For more information about the investigation into e-cigarettes, contact us today.

Additional Reading:

Big Drop in Youth Vaping Thanks to COVID School Closures

FDA Authorizes Vuse Solo E-Cigarette, Shows Benefit for Smokers

FDA Requests More Time to Determine Ruling About E-Cigarettes

FDA Removes 55,000 Flavored Vaping Products From Market

Lupin Pharmaceuticals Recalls Blood Pressure Tablets Due to Possible Carcinogen Contamination

Posted on October 25, 2021October 25, 2021

Lupin Pharmaceuticals issued a voluntarily recall of irbesartan and hydrochlorothiazide tablets. Tests on API batches of these medications revealed possible contamination with a cancer-causing impurity. Both medicines are used to treat high blood pressure and diabetic nephropathy in hypertensive patients with Type 2 diabetes.

Current Recall for Lupin Pharmaceuticals

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above specification limit for the impurity N-nitrosoirbesartan,” the Food and Drug Administration (FDA) reported. N-nitrosoirbesartan is a potential carcinogen for humans.

Between early October 2018 and late September 2021, Lupin Pharmaceuticals received four reports of illness from irbesartan. Patients taking the combination of irbesartan and hydrocholorothiazide tablets reported no illnesses.

Irebesartan was distributed nationwide in 75mg, 150mg, and 300mg formulas. They were sold through wholesalers, drug chains, mail order pharmacies, and supermarkets.

Previous Recalls Due to Potential Carcinogen Contamination

This recall is not Lupin’s first experience with possible carcinogen contamination. During the summer of 2020, the company, along with Sun Pharma, Bayshore Pharmaceuticals, and Granules Pharmaceuticals, pulled metformin, a generic diabetes medication, from the shelves due to batch testing results.

The recalls of metformin were in response to the FDA finding N-nitrosodimethylaine in “sartan”-based blood pressure drugs and heartburn medications, including Zantac. These findings triggered a global recall of all impacted medicines.

For more information about both the Lupin Pharmaceuticals recall and the Zantac recall, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Pharmacy Chains Found Guilty in Recent Trial

What’s Next for Opioid Epidemic Lawsuits

Additional Reading:

Responses to Recent Roundup Case Ruling

The Future of Roundup Settlements

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Largest Single Plaintiff Award in 3M Bellwether Trial

What’s Next for 3M MDL

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Major Victory for Opioid Manufacturers

Future Implications of the Ruling

Additional Reading:

Timeline of Expanded Recall for Chantix

Connection to Other Recent Recalls

Additional Reading:

Petition Against EPA’s Decision

Paraquat Usage Linked to “Unreasonable Risks”

Defense Verdict in Fifth Bellwether Trial for 3M

History of Allegations Against 3M’s Defective CAEv2

Additional Reading:

New Settlement for Johnson & Johnson and Texas

National Opioid Deal

Additional Reading:

Use of E-Cigarettes to Prevent Smoking Relapse

Harmful History of Vaping

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Current Recall for Lupin Pharmaceuticals

Previous Recalls Due to Potential Carcinogen Contamination

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